Blood Compliance Reports (BCR) 2017 September Update

[Stephen-Grayson]

I have received enquiries regarding the revised communication process following the blood compliance report assessment. Whilst I understand the concerns raised, I have attempted to give some background to the approach below for your information.

The blood compliance assessment process results in a compliance score for all sites assessed. This score is used by the MHRA blood inspectorate team to determine which sites we intend to inspect in the current year or not, on the information we have at that time. This decision is based on perceived compliance failures from the compliance report and other sources. We also inspect a number of sites each year that appear compliant to validate the assessment process.
This year the MHRA has decided to change its post assessment communication to advise sites that they have been assessed. The graded compliance letters used in previous years have been withdrawn with all sites receiving the same letter. We do not intend to issue a “compliance letter”. This decision supports a more dynamic risk based approach and is in line with our communications for medicines which was issued in a recent MHRA blog. (https://mhrainspectorate.blog.gov.uk...d-inspections/).

It is anticipated that sites selected for inspection from this year’s assessment (compliance risk or control) will be inspected before the end of May 2018.

[jennyfullthorpe]

If inspections are due to start in October how much notice will be given?
Will all sites due for inspection be notified for the year ahead or is notification an on going process?
Will there be a clear process deeming the site to be in general compliance as before?

[Stephen-Grayson]

The notice of inspection to sites will be given by the allocated inspector on a rolling, per site basis.
The notice period is determined by each inspector and may differ from site to site. Whilst typically 2 weeks notice has been given historically, you should note that short notice and unannounced inspections have also been used in the past, and may still be used, on a per site basis moving forward.
Please refer to the blog referenced above for further information.
As explained above, we do not intend to issue a letter with a determined compliance status for those sites not inspected.